Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY4064809 · 4 trials · 3 indications
As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1
Investigator-assessed
PK: Cmax of LY4064809
PK: AUC of LY4064809
PK: AUC 0-tlast, where t is the last time point with a measurable concentration
PK: AUCinf
| Arm | Type | Description |
|---|---|---|
| LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 1) | EXPERIMENTAL | LY4064809 given orally in one of two doses in combination with investigator's choice of CDK4/6 inhibitor given orally and ET given orally or intramuscularly |
| LY4064809 + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2) | EXPERIMENTAL | LY4064809 given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly |
| Placebo + CDK4/6 Inhibitor + Endocrine Therapy (ET) (Part 2) | PLACEBO_COMPARATOR | Placebo given orally in combination with CDK4/6 inhibitor given orally and ET given orally or intramuscularly |
| LY4064809 | EXPERIMENTAL | - |
| Group 1 Treatment A Fasted | EXPERIMENTAL | LY4064809 administered orally |
| Group 1 Treatment B High-Fat Meal | EXPERIMENTAL | LY4064809 administered orally |
| Group 2 Treatment A Fasted | EXPERIMENTAL | LY4064809 administered orally |
| Group 2 Treatment C Proton Pump Inhibitor (PPI) Effect | EXPERIMENTAL | LY4064809 administered orally with esomeprazole |
| Name | Type | Description |
|---|---|---|
| LY4064809 | DRUG | Administered orally |
| Placebo | DRUG | Administered orally |
| Ribociclib | DRUG | Administered orally |
| Palbociclib | DRUG | Administered orally |
| Abemaciclib | DRUG | Administered orally |
| Anastrozole | DRUG | Administered orally |
| Letrozole | DRUG | Administered orally |
| Exemestane | DRUG | Administered orally |
| Fulvestrant | DRUG | Administered intramuscular |
| [14C]-LY4064809 | DRUG | Administered by IV infusion |
Inclusion Criteria: * Are willing to follow contraception requirements. Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical trials. * If assigned female at birth, pre-/peri- and postmenopausal statu...
LY4064809, also known as tersolisib, is an investigational small molecule being studied for the treatment of advanced breast cancer with a PIK3CA genetic change. It is being evaluated in combination with other anti-cancer treatments in a Phase 3 clinical trial enrolling participants with breast neoplasms and metastasis.
LY4064809 targets the PIK3CA gene. It is being studied in patients whose tumors carry a PIK3CA genetic change, as part of a Phase 3 trial for advanced breast cancer. The drug is designed to act on this specific genetic alteration.
LY4064809 is being developed by Eli Lilly and Company, a pharmaceutical company listed on the stock exchange under the ticker LLY. The drug is also known as tersolisib and is currently in clinical development for oncology indications.
LY4064809 is in Phase 3 clinical development for advanced breast cancer with a PIK3CA genetic change. It is an investigational drug and has not been approved by regulatory authorities. Earlier Phase 1 studies in healthy participants have been completed.
LY4064809 is being studied in a Phase 3 trial, NCT07174336, which is recruiting 800 participants with advanced breast cancer and PIK3CA mutations across multiple countries. Additional Phase 1 studies in healthy participants, including NCT07247357, NCT07339735, and NCT07519525, have been completed.
Yes, LY4064809 is also known as tersolisib. The Phase 3 clinical trial for advanced breast cancer refers to the drug as tersolisib (LY4064809/STX-478). Both names refer to the same investigational small molecule being developed by Eli Lilly and Company.